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FDA 510(k)

MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER

K-Number: K910282 · 1991-03-29

ApplicantGraphic Controls Corp.
Decision Date1991-03-29
Product CodeHFM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Graphic Controls Corp.. It received FDA 510(k) clearance on 1991-03-29 under 510(k) number K910282. The device is classified under product code HFM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER?

MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER is a medical device that received FDA 510(k) clearance on 1991-03-29. The listed applicant is Graphic Controls Corp.. The 510(k) number is K910282.

When did MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER receive FDA 510(k) clearance?

MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER received FDA 510(k) clearance on 1991-03-29, under 510(k) number K910282.

Who is the listed applicant for MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER?

The FDA 510(k) record lists Graphic Controls Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER?

The FDA product code for MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER is HFM.

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Other records listing Graphic Controls Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K981964MEDI-TRACE 4103 NEONATAL ELECTRODEK983287MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEK974730SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)K980857MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODEK972970MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEK964387POINT OF USE II SHARPS-A-GATOR

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Related Devices (Code: HFM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061044FEATHERLITE AQUA TOCODYNAMOMETERVentrex, Inc.K040392TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGAmerican I.V. Products, Inc.K013477TOCO LITE, MODEL TD-01Ventrex, Inc.K994353SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565Precision Dynamics Corp.K992811TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGEpic Medical Equipment Services, Inc.K954847DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIESOcg Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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